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EC number: 700-055-7 | CAS number: 630113-05-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 22 April to 08 May, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guidline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [3-(2-{dimethyl[3-(2-methylprop-2-enamido)propyl]azaniumyl}acetamido)propyl][(2R)-2-hydroxy-3-(trimethylazaniumyl)propyl]dimethylazanium [3-(2-{dimethyl[3-(2-methylprop-2-enamido)propyl]azaniumyl}acetamido)propyl][(2S)-2-hydroxy-3-(trimethylazaniumyl)propyl]dimethylazanium hexachloride
- EC Number:
- 700-055-7
- Cas Number:
- 630113-05-2
- Molecular formula:
- C22 H48 N5 O3.3Cl
- IUPAC Name:
- [3-(2-{dimethyl[3-(2-methylprop-2-enamido)propyl]azaniumyl}acetamido)propyl][(2R)-2-hydroxy-3-(trimethylazaniumyl)propyl]dimethylazanium [3-(2-{dimethyl[3-(2-methylprop-2-enamido)propyl]azaniumyl}acetamido)propyl][(2S)-2-hydroxy-3-(trimethylazaniumyl)propyl]dimethylazanium hexachloride
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 98
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-Napthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Doses adjusted for content of the main constituent
Experiment 1: 3; 10; 33; 100; 333; 1000; 2500; and 5000; µg/plate
Experiment 2: 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: acceptable solubility of test substance
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535; TA 100 without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine, 4-NOPD
- Remarks:
- TA 1537; TA 98 without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1535; TA 1537; TA 98, TA100, Wp2 uvrA with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: experiment 1: plate incorporation; experiment 2: preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
There were no toxic effects. Plates
incubated with the test item showed normal background growth up to
5000µg/plate with and without S9 mix in both experiments.
No substantial increase in revertant colony numbers of any of the 5
tester strains was observed following treatment with TRIQUAT MONOMER at
any dose level, neither in the presence nor absence of metabolic
activation (S9 mix). There was also no tendency of higher mutation rates
with increasing concentrations in the range below the generally
acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and these showed a distinct increase of induced revertant colonies.
Results of Gene Mutation Assay: Pre-experiment and Experiment 1:
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ±SD) |
|||||
|
|
|
|
|
|
|||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|||
Without Activation |
Deionised water |
14 ± 2 |
15 ± 4 |
37 ± 3 |
150 ± 12 |
49 ± 10 |
||
Untreated |
14 ± 4 |
16 ± 2 |
39 ± 5 |
129 ± 20 |
50 ± 1 |
|||
Triquat |
3 µg |
14 ± 3 |
18 ± 3 |
33 ± 5 |
153 ± 18 |
35 ± 4 |
||
Monomer |
10 µg |
17 ± 2 |
17 ± 2 |
35 ± 2 |
157 ± 8 |
48 ± 4 |
||
33 µg |
15 ± 1 |
15 ± 3 |
34 ± 1 |
143 ± 9 |
46 ± 3 |
|||
100 µg |
11 ± 2 |
15 ± 2 |
36 ± 1 |
150 ± 8 |
43 ± 6 |
|||
333 µg |
13 ± 1 |
18 ± 4 |
28 ± 2 |
148 ± 10 |
37 ± 6 |
|||
1000 µg |
14 ± 5 |
15 ± 5 |
29 ± 3 |
145 ± 6 |
44 ± 8 |
|||
2500 µg |
14 ± 3 |
18 ± 3 |
33 ± 7 |
167 ± 11 |
50 ± 2 |
|||
5000 µg |
19 ± 4 |
19 ± 4 |
30 ± 3 |
187 ± 10 |
54 ± 2 |
|||
NaN3 |
10 µg |
2121 ± 70 |
2568 ± 110 |
|||||
4-NOPD |
10 µg |
543 ± 23 |
||||||
4-NOPD |
50 µg |
106 ± 13 |
||||||
MMS |
3.0 µL |
1283 ± 21 |
||||||
With Activation |
Deionised water |
17 ± 2 |
24 ± 5 |
45 ± 5 |
171 ± 5 |
70 ± 7 |
||
Untreated |
17 ± 3 |
21 ± 8 |
46 ± 4 |
160 ± 7 |
66 ± 3 |
|||
Triquat |
3 µg |
17 ± 8 |
24 ± 4 |
43 ± 8 |
142 ± 11 |
56 ± 7 |
||
Monomer |
10 µg |
18 ± 1 |
23 ± 3 |
39 ± 5 |
156 ± 16 |
67 ± 5 |
||
33 µg |
21 ± 4 |
20 ± 1 |
34 ± 7 |
177 ± 9 |
66 ± 9 |
|||
100 µg |
17 ± 5 |
21 ± 1 |
41 ± 2 |
159 ± 19 |
49 ± 13 |
|||
333 µg |
17 ± 3 |
21 ± 1 |
36 ± 1 |
157 ± 7 |
59 ± 12 |
|||
1000 µg |
14 ± 2 |
25 ± 2 |
46 ± 5 |
152 ± 6 |
65 ± 2 |
|||
2500 µg |
14 ± 1 |
26 ± 3 |
44 ± 8 |
147 ± 8 |
65 ± 5 |
|||
5000 µg |
24 ± 3 |
22 ± 4 |
39 ± 5 |
138 ± 14 |
60 ± 8 |
|||
2-AA |
2.5 µg |
403 ± 10 |
297 ± 13 |
2145 ± 42 |
2447 ± 104 |
|||
2-AA |
10.0 µg |
297 ± 5 |
||||||
Key to Positive Controls |
|||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
Results of Gene Mutation Assay: Experiment 2:
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ±SD) |
|||||
|
|
|
|
|
|
|||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|||
Without Activation |
Deionised water |
16 ± 4 |
12 ± 4 |
32 ± 9 |
137 ± 12 |
58 ± 5 |
||
Untreated |
17 ± 0 |
17 ± 7 |
27 ± 4 |
134 ± 6 |
55 ± 7 |
|||
Triquat |
33 µg |
16 ± 6 |
9 ± 1 |
30 ± 7 |
135 ± 12 |
49 ± 2 |
||
Monomer |
100 µg |
17 ± 3 |
12 ± 5 |
30 ± 9 |
136 ± 11 |
53 ± 3 |
||
333 µg |
17 ± 3 |
13 ± 3 |
30 ± 10 |
128 ± 11 |
58 ± 10 |
|||
1000 µg |
13 ± 4 |
10 ± 3 |
29 ± 7 |
134 ± 7 |
55 ± 6 |
|||
2500 µg |
17 ± 2 |
11 ± 2 |
34 ± 3 |
132 ± 12 |
60 ± 3 |
|||
5000 µg |
16 ± 8 |
15 ± 1 |
31 ± 4 |
131 ± 8 |
60 ± 9 |
|||
NaN3 |
10 µg |
2040 ± 40 |
2152 ± 55 |
|||||
4-NOPD |
10 µg |
491 ± 55 |
||||||
4-NOPD |
50 µg |
124 ± 5 |
||||||
MMS |
3.0 µL |
635 ± 85 |
||||||
With Activation |
Deionised water |
21 ± 6 |
16 ± 4 |
39 ± 3 |
172 ± 12 |
59 ± 8 |
||
Untreated |
16 ± 3 |
14 ± 1 |
46 ± 11 |
161 ± 25 |
58 ± 9 |
|||
Triquat |
33 µg |
22 ± 2 |
16 ± 4 |
35 ± 4 |
176 ± 13 |
57 ± 8 |
||
Monomer |
100 µg |
23 ± 6 |
16 ± 3 |
39 ± 8 |
174 ± 12 |
61 ± 9 |
||
333 µg |
22 ± 4 |
18 ± 3 |
43 ± 11 |
176 ± 12 |
66 ± 5 |
|||
1000 µg |
18 ± 5 |
19 ± 0 |
38 ± 5 |
159 ± 12 |
64 ± 6 |
|||
2500 µg |
24 ± 4 |
15 ± 7 |
35 ± 10 |
159 ± 14 |
61 ± 4 |
|||
5000 µg |
23 ± 1 |
15 ± 6 |
36 ± 12 |
163 ± 11 |
63 ± 10 |
|||
2-AA |
2.5 µg |
245 ± 7 |
125 ± 10 |
1041 ± 58 |
977 ± 93 |
|||
2-AA |
10.0 µg |
227 ± 25 |
||||||
Key to Positive Controls |
|||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
During the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frame shifts in the genome of the strains used. - Executive summary:
This study was performed to investigate the potential of TRIQUAT MONOMER to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations of the active ingredient (main constituent):
Pre-Experiment/Experiment I: 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 33; 100; 333; 1000; 2500; and 5000 µg/plate
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments.
No toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), occurred in the test groups with or without metabolic activation.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with TRIQUAT MONOMER at any dose level, either in the presence or absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, in the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, TRIQUAT MONOMER is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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